As a Senior Manager, Nonclinical Studies you will work closely with internal Preclinical, Toxicology, Regulatory, and Clinical staff as a subject matter expert in nonclinical study design, and you will with work with external CROs to provide oversight in the review and/or QC of study proposals, protocols, data, and reports, in support of Athenex development programs. You will participate in project team meetings and help to manage and drive nonclinical timelines for regulatory submissions. You will serve a technical writing role, composing nonclinical summaries and/or reports for pharmacology, pharmacokinetic pharmacology studies conducted by or on behalf of Athenex, and be an expert user of the nonclinical document templates that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.
Key responsibilities include the following:
· Assist Scientific Managers and Toxicologists with CRO management activities, including communicating with study directors, obtaining and reviewing study proposals, composing and reviewing protocols/reports, and meeting study timelines.
· Perform routine oversight of CROs to ensure study adherence with regulatory requirements/GLP compliance.
· Compose and manage review/QC cycles for nonclinical summaries and documents in collaboration with subject matter experts.
· Lead discussions regarding nonclinical study requirements, documents, and timelines in context with the overall program development of a drug.
· Performs other duties as assigned.
Required Education and Qualifications
· Ph.D. (or equivalent degree) and 3+ years relevant work experience
· M.S. (or equivalent degree) and 6+ years relevant work experience
· Excellent written and oral communication, interpersonal and problem-solving skills
· Strong understanding of how to manage nonclinical studies, organize nonclinical data, and write research reports.
· Understanding of the drug development process and global regulatory guidance
· Proficient in Microsoft® Suite (Word, Excel, PowerPoint, Project). Experience with electronic document management and tracking systems is a plus.
o Experience in oncology, toxicology, and/or pharmacokinetics
o Experience in scientific writing
o Resourcefulness, pragmatism, and independent work ethic
o Can manage multiple projects under tight timelines, working independently and collaboratively
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.